Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.

Inclusion criteria

• One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
• In addition, at least one of the following high-risk clinical syndromes:
• Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
• Rapidly declining kidney function with a reduction in estimated GFR of \>5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
• Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, "flash" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction \<40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
• All 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication.

Exclusion criteria

• Unable to provide informed consent.
• Treatment-resistant heart failure episodes presumed caused by renovascular disease.
• Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
• Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization.
• Pregnancy or unknown pregnancy status in female of childbearing potential.
• Kidney size \<7 cm (pole to pole length) supplied by target vessel.
• Previous kidney transplant.
• Previous PTRA treatment.
• Presence of a renal artery stenosis not amenable for treatment with a stent.
• Patients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period.
• Patients treated with renal artery stenting without randomization in the study period include patients with:
• Treatment-resistant heart failure episodes presumed caused by renovascular disease.
• Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
• At least one of the listed high-risk clinical syndromes AND one or more significant atherosclerotic renal artery stenoses defined as a stenosis of 50-69% by catheter-based angiography with:
• a mean translesional gradient of ≥10 mm Hg, or
• a systolic translesional gradient of ≥20 mm Hg, or
• a renal fractional flow reserve (Pd/Pa) of ≤0.8